Working with biologically active compounds requires increased safety measurements in the production facility to protect employees against potential hazards or intoxication. Biologically active compounds are often produced or used for pharmaceutical purposes which are the reasons why requirements of stringent cleanliness must be complied during manufacture. The routine construction of facilities for the manufacture of ultrapure compounds is composed of a first, internal chamber which is outwards closed and which is surrounded by a second chamber. In the second chamber the persons working with the biological material are residing, while the processing of the biological material occurs mainly in the first chamber. Both chambers are connected with each other through lockable sluices. The first chamber is typically a glovebox so that the process steps may be accomplished from the second chamber with the aid of gloves. The second chamber is typically insulated from the outside, but connected to it through lockable sluices. In both chambers there are ideally sterile conditions which satisfies clean room requirements. To prevent contamination of the biologically active material with surrounding particles, microbiological germs and the like, an over pressure prevails in the first chamber, which is typically an over pressure of 15 Pa. In contrast thereto, within the second chamber there exists a low pressure compared to the first chamber, but an over pressure in relation to the ambient pressure. Therefore, particles or germs from the second chamber will be prevented from infiltrating the first chamber. Thus, the biologically active material will be protected against contamination from the environment.
In the case of manufacture of biologically active compounds by a fermentational process, there are process steps which are carried out, at least temporarily, in an open apparatus. Inoculation is for example such a process step. In the majority of cases this step has to be conducted manually. During this procedure in which the device (container, vial) containing the starting material (cell bank) is opened, if only shortly, aerosols may be formed. Furthermore, during the intermediate steps of the preculture stages until the start of fermentation, a port of the fermenter may be opened, if only shortly, which may create aerosols. Likewise it is possible that during processing of the fermentation product, ie. the biologically active substance, aerosols may be formed. Thus there is a risk of exposing the environment to germs, bacteria or toxic substances. Because of the relative low pressure in the second chamber in relation to the first chamber, aerosols from the first chamber may infiltrate the second chamber and can lead to a threat for the persons working in the second chamber. Nevertheless, ensure operational safety, more precautions in this case must be set, as for example vaccination of the employees, wearing of protective clothing, etc.